Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL)
AVAIL
1 other identifier
interventional
120
1 country
3
Brief Summary
Hot flashes are a common and debilitating symptom among prostate cancer patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that venlafaxine provides partial relief, but the tolerability is poor when the dose is not tapered. Hence, an alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2021
CompletedFirst Posted
Study publicly available on registry
October 6, 2021
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedNovember 7, 2023
November 1, 2023
1.6 years
September 26, 2021
November 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weekly mean hot flash symptom severity score (HFSSS)
The HFSSS is defined as the product of "hot frequency" and "hot severity". The severity of hot flashes is assessed based on the duration of hot flashes and physical and emotional symptoms; it is scored as mild, moderate, severe, and very severe (range 1-4, from mild to very severe).
Baseline to week 6
Secondary Outcomes (6)
Weekly mean hot flash symptom severity score (HFSSS)
Baseline to week 14
Response rate of HFSSS
Baseline, week 6, and week 14
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Baseline, week 6, and week 14
International Index of Erectile Function (IIEF-5)
Baseline, week 6, and week 14
The Zung Self-Rating Anxiety Scale (SAS)
Baseline, week 6, and week 14
- +1 more secondary outcomes
Study Arms (3)
Acupuncture
EXPERIMENTALLicensed acupuncturists with more than 5 years of experience will be responsible for administering interventions three times per week for 6 weeks. The needles (30 or 40 mm and 0.25 mm gauge; Soochow, Hwato) will be inserted and manipulated until De Qi, a sensation of soreness and tingling. Acupuncture was defined as targeting the 10 bilateral acupuncture points: Xinshu (BL15), Shenshu (BL23), Zhongliao (BL33), Sanyinjiao (SP6), Yinlingquan (SP9). The needle will be left in place for 30 minutes with brief manipulation at the beginning, middle, and end of therapy.
Sham Acupuncture
SHAM COMPARATORTreatment will be the same for the sham acupuncture, except for the following: the acupuncturist selected the same number of nonacupuncture, nontrigger points. Instead of eliciting De Qi, the needles will be minimally manipulated to avoid eliciting sensations other than initial contact with skin.
Usual Care
NO INTERVENTIONPatients receiving usual care received neither acupuncture nor sham acupuncture. After the 6-week assessment, patients will be offered the option to receive acupuncture treatment as the acupuncture group.
Interventions
For the active acupuncture group, the acupuncturist chose standard points depending on subjects' preferred positions. In addition, up to four acupuncture points were chosen on the basis of subjects' other presenting symptoms (such as fatigue, insomnia, or erectile dysfunction). The needles (30 or 40 mm and 0.25 mm gauge; Soochow, Hwato) will be inserted and manipulated until De Qi, a sensation of soreness and tingling.
Treatment will be the same for the sham acupuncture, except for the following: the acupuncturist selected the same number of nonacupuncture, nontrigger points. Instead of eliciting De Qi, the needles will be minimally manipulated to avoid eliciting sensations other than initial contact with skin.
Eligibility Criteria
You may qualify if:
- patients aging from 18 to 75 years diagnosed with prostate cancer undergoing ADT;
- with an average of 3 or more hot flashes a day for at least 3 days before enrollment and no other clinically significant disease;
- not receiving any medications for hot flashes nor did they have a previous history of acupuncture treatment.
You may not qualify if:
- hormonal treatment other than GnRH analogue
- daily treatment with psychotropic drugs
- newly started or changed alternative medications with possible effects on flushes uncontrolled hypertension or metabolic disease
- inability to move/lie on the side, and treatment with anticoagulants or pacemaker.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital
Nanjing, Jiangsu, China
Yantai Hospital of Traditional Chinese Medicine
Yantai, Shandong, China
West China Hospital
Chengdu, Sichuan, China
Related Publications (1)
Qin Z, Zang Z, Yu J, Lv J, Li N, Zhang J, Yang M, Kwong JSW, Pang R, Wang J, Cui Z, Yu Y, Wang H, Zhu Y, Yuan Y, Li X, Wu Y, Wu J. Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial. BMC Complement Med Ther. 2023 Oct 27;23(1):388. doi: 10.1186/s12906-023-04218-y.
PMID: 37891531DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiani Wu, M.D., Ph.D.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The principal investigator, study investigators, patients, study staff, and the statistician will be blinded to the treatment assignments among interventions. The acupuncturists cannot be blinded to verum acupuncture or the sham owing to the characteristics of acupuncture procedure. Patients allocated to both verum acupuncture and sham acupuncture groups will be asked to guess which type of acupuncture (verum acupuncture, sham acupuncture, or unclear) they had received after the end of last treatment.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
September 26, 2021
First Posted
October 6, 2021
Study Start
June 1, 2022
Primary Completion
December 31, 2023
Study Completion
June 30, 2024
Last Updated
November 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- With publication
- Access Criteria
- For a specified purpose with a signed data access agreement
The deidentified participant data will be shared after publication. Researchers can access the data with a specific purpose and a signed data access agreement.